Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3)
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Purpose
This Phase IIIb, randomized, multi-national, multi-center, blinded study of Infliximab (IFX) in subjects aged 18 and older with active RA is being conducted to assess whether increasing either the infusion dose or infusion frequency in patients presenting with a disease flare after an initial response to infliximab results in a significant improvement in disease activity.
Subjects responding to an initial infliximab treatment regimen, who flare during continuation of treatment at 3 mg/kg administered every 8 weeks, will be randomly assigned to one of 3 different dosing regimens of infliximab and will be treated for 4 or 5 consecutive infusions for a total duration of 24 weeks. The infliximab control group and the infliximab increased dose group are evaluator and subject-blinded. The increased frequency group is not blinded. Clinical assessments of disease activity will be based the European League Against Rheumatism (EULAR) criteria for response. Safety parameters will be assessed at every infusion.
A disease flare is defined by an increase in DAS28 with 0.6 or more at screening, when compared to the DAS28 score measured immediately prior to the last Remicade® infusion and depends upon the actual score as well. Since prior to enrollment, the subject received Remicade® as per routine clinical practice, the days on which infusions were administered and assessments are done during the induction period do not have to be exactly at Week 2, 6 and 14.
- Drug: Infliximab Control (double-blinded)
- Drug: Infliximab Increased Dose (double-blinded)
- Drug: Infliximab Increased Frequency (open-label)
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Infliximab Increased Frequency Drug: Infliximab Increased Dose Drug: Infliximab Control |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomised Controlled Trial Evaluating Strategies to Optimize Disease Activity Control in RA Patients Treated With Infliximab in Clinical Practice. |
- Change in Disease Activity Score Based on 28 Joint Count (DAS28) Score. [ Time Frame: Between Screening (Week <=1) and Week 24 ] [ Designated as safety issue: No ]
| Enrollment: | 43 |
| Study Start Date: | March 2006 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Increased Frequency
Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
|
Drug: Infliximab Increased Frequency
Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks for 24 weeks
Other Name: Increased Frequency
|
|
Experimental: Increased Dose
3 mg/kg infliximab + 1 extra vial (100 mg) infliximab, every 8 weeks
|
Drug: Infliximab Increased Dose
3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks for 24 weeks
Other Name: Increased Dose
|
|
Active Comparator: Control
Continuation of infliximab 3 mg/kg every 8 weeks
|
Drug: Infliximab Control
Continuation of infliximab 3 mg/kg every 8 weeks for 24 weeks
Other Name: Control
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- aged 18 years or more
- with RA according to ACR criteria
- presented with a disease flare after initial response to infliximab, with both response and flare being defined using the DAS28 score (EULAR criteria)
- received the standard Remicade® dosing schedule per the EU label (3 mg/kg at Weeks 0, 2, 6, [and 14])
- an initial response documented by moderate or good DAS28 improvement (EULAR criteria) from Week 0 to Week 6 or 14.
Exclusion Criteria:
- a female who is, or intends to become, pregnant during or within 6 months of the end of the study, is nursing or not using adequate contraceptive measures
- has not observed the designated periods for concomitant medications
- used any investigational medical product within 30 days prior to Baseline
- any clinically significant deviation from normal in the physical examination or chest X-ray that in the investigator's judgment, may interfere with the study evaluation or affect subject safety
- rheumatic disease other than RA or has any systemic inflammatory condition with signs and symptoms that might confound the evaluations of safety and toxicity
- allergic reaction/sensitivity to the study drug or its excipients that requires corticosteroid pre-infusion medication.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00394589 History of Changes |
| Other Study ID Numbers: | P04249 |
| Study First Received: | October 31, 2006 |
| Results First Received: | October 28, 2009 |
| Last Updated: | February 3, 2010 |
| Health Authority: | Austria: Federal Ministry for Health and Women Belgium: Ministry of Social Affairs, Public Health and the Environment Denmark: Danish Medicines Agency France: Ministry of Health Germany: Paul-Ehrlich-Institut Greece: Ministry of Health and Welfare Netherlands: Medicines Evaluation Board (MEB) Norway: Norwegian Medicines Agency Portugal: National Pharmacy and Medicines Institute Sweden: Medical Products Agency Turkey: Ministry of Health |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Infliximab Dermatologic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 19, 2013